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Prospective Evaluation of Hypofractionation Proton Beam Therapy With Concurrent Treatment of the Prostate and Pelvic Nodes for Clinically Localized, High Risk or Unfavorable Intermediate Risk Prostate Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2016 by Mayo Clinic
Sponsor:
Information provided by (Responsible Party):
Chunhee Richard Choo, M.D., Mayo Clinic
ClinicalTrials.gov Identifier:
NCT02874014
First received: August 17, 2016
Last updated: December 8, 2016
Last verified: December 2016
  Purpose
The study is to examine a moderate hypofractionation regimen of proton beam therapy for high risk or unfavorable intermediate risk prostate cancer. The prostate and seminal vesicles are treated with 6750 centigray (RBE) in 25 fractions (i.e. 270 centigray/fraction), while the regional pelvic nodes receive 4500 centigray (RBE) in 25 fractions (i.e. 180 centigray/fraction) simultaneously. The overall treatment time is 5 weeks.

Condition Intervention
Prostate Cancer
Radiation: Hypofractionation Proton beam therapy with Concurrent Treatment of the Prostate and Pelvic Nodes

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Prospective Evaluation of Hypofractionation Proton Beam Therapy With Concurrent Treatment of the Prostate and Pelvic Nodes for Clinically Localized, High Risk or Unfavorable Intermediate Risk Prostate Cancer

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Late grade ≥ 3 Gastrointestinal (GI) and Genitourinary (GU) toxicity of interest, using the CTCAE v4.0 [ Time Frame: 24 months post proton beam therapy ]

Secondary Outcome Measures:
  • Late grade ≥ 2 GI and GU toxicity of interest, using the CTCAE v4.0 [ Time Frame: 24 months post proton beam therapy ]
  • Acute grade ≥ 3 GI and GU toxicity of interest, using the CTCAE v4.0 [ Time Frame: Within 3 months post proton beam therapy ]
  • Disease-free survival including freedom from PSA relapse [ Time Frame: 5 years post proton beam therapy ]
  • Disease-specific survival [ Time Frame: 5 years post proton beam therapy ]

Estimated Enrollment: 51
Study Start Date: July 2016
Estimated Primary Completion Date: August 2021 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Hypofractionation Proton beam therapy
Hypofractionation Proton beam therapy with Concurrent Treatment of the Prostate and Pelvic Nodes
Radiation: Hypofractionation Proton beam therapy with Concurrent Treatment of the Prostate and Pelvic Nodes

Detailed Description:

Proton beam therapy can provide a therapeutic gain by offering at least equivalent (or superior) tumor control while reducing the risk of radiation toxicity, in comparison with conventional photon-based external beam radiotherapy, given its dose-deposition characteristics. Currently the clinical target volume of proton beam for the treatment of prostate cancer has been mostly limited to the prostate and the seminal vesicles. There has been no study of proton beam therapy to treat both the primary tumor in the prostate and the regional pelvic nodes simultaneously using a moderate hypofractionation regimen.

The study is a prospective, single-arm, clinical trial to evaluate a moderate hypofractionation regimen of proton beam therapy for high risk or unfavorable intermediate risk prostate cancer. The clinical target volumes of proton beam therapy include both the prostate/seminal vesicles and the regional pelvic nodes. The primary objective is to assess late grade ≥ 3 gastrointestinal (GI) and genitourinary (GU) toxicity. The secondary objectives are to evaluate late grade ≥ 2 GI and GU toxicity, acute grade ≥ 3 GI and GU toxicity, and disease-free survival including freedom from PSA (prostate specific antigen) relapse at 5 years. The study provides an avenue to examine the safety, efficacy, cost effectiveness, and convenience of a moderate hypofractionation regimen (5-week course) of proton beam therapy.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male; Age ≥ 18 years.
  • Histological confirmation of adenocarcinoma of the prostate within 6 months of study enrollment.
  • Clinical stage T1-2 N0 M0, Gleason Score 7, Prostate Specific Antigen (PSA) 20-100 ng/mL, or Clinical stage Any T N0 M0, Gleason Score 8-10, PSA ≤ 100 ng/mL, or Clinical stage T3-4 N0 M0, any Gleason Score, PSA ≤ 100 ng/mL, or Clinical stage T1-2 N0 M0, Gleason Score 4+3, PSA 10-20 ng/mL
  • Zubrod performance score (PS) ≤ 1
  • Total bilirubin, aspartate aminotransferase, alkaline phosphatase, and serum creatinine: < 2 x upper normal limit
  • Signed informed consent.

Exclusion Criteria:

  • Any known nodal (N1) or distant metastasis (M1)
  • Previous androgen deprivation therapy lasting more than 6 months
  • History of inflammatory bowel disease
  • Presence of a hip prosthesis
  • Prior pelvic radiotherapy or prostatectomy
  • Prior or concurrent antineoplastic agents (chemotherapy)
  • Previous or concurrent malignancy other than non-melanoma skin cancer within 5 years of diagnosis of prostate cancer.
  • Inability to start the protocol treatment within 1 month after study enrollment.
  • Medical or psychiatric conditions that preclude informed decision-making or compliance with the protocol treatment or follow-up
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02874014

Contacts
Contact: Clinical Trials Referral Office 855-776-0015
Contact: Adam Amundson amundson.adam1@mayo.edu

Locations
United States, Arizona
Mayo Clinic in Arizona Recruiting
Scottsdale, Arizona, United States, 85259
United States, Minnesota
Mayo Clinic in Rochester Recruiting
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Richard Choo, MD Mayo Clinic
  More Information

Responsible Party: Chunhee Richard Choo, M.D., PI, Mayo Clinic
ClinicalTrials.gov Identifier: NCT02874014     History of Changes
Other Study ID Numbers: 15-009528
Study First Received: August 17, 2016
Last Updated: December 8, 2016

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on March 24, 2017